Absence of QT_cProlongation with Cetirizine in Children Aged 6 to 11 Years

Abstract

Background: In previous clinical trials, cetirizine has been shown to be efficacious in the treatment of seasonal allergic rhinitis (SAR), perennial allergic rhinitis, and chronic idiopathic urticaria when given once daily. As significant QT prolongation and cardiac arrhythmias have been reported with some of the newer antihistamines, the electrocardiographic effects of cetirizine were evaluated. A previous study in normal, healthy, adult volunteers had demonstrated that cetirizine does not prolong the QT interval at up to six

Clinical and Pharmacological Peculiarities of Cetirizine Use for the Therapy of Allergic Diseases in Children

“…The frequency of adverse events was the same as in the placebo group; no tachyphylaxis was observed [18]. Furthermore, cetirizine has no cardiotoxic effect; it does not extend the QT and QT(c) intervals [18][19][20]. Zyrtec is the only 2 nd generation medication approved for use in the Russian Federation from the age of 6 months, whereas the minimum age for prescribing other 2 nd generation antihistamines is 2 years.…”

Cetirizine

“…Somnolence occurred in cetirizine recipients [3 of 9 patients in 1 study and 1 of a total study population of 80 in the other (parallel design study; patient numbers per group not given)], but not in patients receiving the alternative agents. [25,46] However, the 5mg regimen caused a statistically, but not clinically, significant decrease in QT c interval versus baseline in 2 of 3 analyses performed; 121 children provided ECG data according to protocol, but 202 provided sufficient information for end-point analysis. [25,46] However, the 5mg regimen caused a statistically, but not clinically, significant decrease in QT c interval versus baseline in 2 of 3 analyses performed; 121 children provided ECG data according to protocol, but 202 provided sufficient information for end-point analysis.…”

“…Effects on non-IgE-mediated hypersensitivity [7,19,20] May have an intrinsic bronchodilatory effect in patients with asthma or exercise-induced bronchoconstriction b Reduced the decrease in FEV1 after exercise or hyperosmolar challenge in children with asthma CNS effects [7,8,14,[21][22][23] Few effects on subjective or objective assessments of drowsiness in volunteers at single doses of 5 to 20mg Few effects on objective assessments of cognitive function in volunteers at single doses of 5 to 20mg No CNS dysfunction according to P300-event-related potential studies in volunteers, in contrast with hydroxyzine A 10mg dose causes less sedation than ketotifen 1mg and oxatomide 30mg Associated with similar or greater sedative effects (but of a similar type) when compared with terfenadine and loratadine at therapeutic doses Statistically significantly altered EEG activity at a dose of 10mg in a study of 16 volunteers Caused sedation in small numbers of children in clinical trials (section 4) Does not potentiate the CNS depressant effects of alcohol (ethanol) Cardiovascular effects [7,[24][25][26][27][28][29] No effect on QT or QTc interval in healthy male volunteers even at high doses (20 or 60 mg/day for 14 days) Generally has no effect on QTc interval in children ECG parameters remain within the normal range, rhythm is sinusal and no arrhythmias (including torsades de pointes) are observed in children receiving 10 mg/day for 14 days with or without erythromycin Nonsignificantly increases heart rate in healthy male volunteers Little or no effect on K + channels in vitro in contrast with terfenadine and astemizole; e.g. the IC50 of cetirizine was 108 vs 0.096 μmol/L for terfenadine and cetirizine has 1000 to 10 000 times lower affinity for K + channels than histamine H1 receptors Appears to have low potential for accumulation in lean tissue such as the myocardium a Inflammatory mediators included allergen (grass pollen, ragweed extract), methacholine, platelet activating factor and compound 48/80.…”

Newer‐generation antihistamines and the risk of adverse events in children: A systematic review

“…Cetirizine was compared with placebo in 16 RC Ts. 14,21,26,32,[34][35][36]40,43,44,[48][49][50]53,54,[56][57][58] Overall, the occurrence of adverse events was generally similar in both groups. Half of the RCTs provided information regarding drug-related adverse ev ents.…”